OmniPore Surgical Implant OP7542Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855421005659), received between Aug 27, 2021 and Aug 27, 2021 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K123908); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, A PATIENT IS UNDERGOING A SURGERY REVISION DUE TO AN INFECTION OF A RIGHT MANDIBULAR IMPLANT. THE DEVICE WAS IMPLANTED ON (B)(6) 2021 AND THE INFECTION WAS REPORTED ON JUNE 27TH 2021.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12379608 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123908. One submission often covers many models, so check the product and lot details in each record.

• Z-1224-2019 · Jan 30, 2019 · Terminated
  OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applicatio
• Z-1223-2019 · Jan 30, 2019 · Terminated
  OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applicatio
• Z-1382-2017 · Jan 25, 2017 · Terminated
  OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right